Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/19

16 August 2016

Dear Sirs,

Commercial Information Circular No. 670/2016

US : FDA Amends Food Facilities Registration Requirements

The US Food and Drug Administration (FDA) has recently amended its regulations for registration of food facilities that require domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the US to register with FDA. This final rule will support the FDA's efforts to act quickly in response to food-related emergencies and will help FDA to use its inspectional resources more efficiently. The final rule will be effective on 12 September 2016 although some of the changes will not take effect until 2020.

DETAILS

2.              By way of background, the FDA Food Safety Modernization Act (FSMA), enacted on 4 January 2011, amended the Federal Food, Drug, and Cosmetic Act (the Act). Among other things, it requires food facilities to register with FDA, renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. 
 
3.              The final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA.  Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Act.  The rule also expands the number of establishments that are considered retail food establishments, which are exempted from the registration requirement.  For more details on the final rule, please refer to the Federal Register and the relevant FDA's webpage at the following links: https://www.federalregister.gov/articles/2016/07/14/2016-16531/amendments-to-registration-of-food-facilities and
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm440988.htm.

ENQUIRIES

4.For enquiries concerning this circular, please contact Mr Lewis LAU at telephone number 2398 5405. 

Yours faithfully,

(Miss Janice LAU)
for Director-General of Trade and Industry

 

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.